(78 days)
The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.
This document is a 510(k) summary for the Laport® Trocars. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in a quantitative, statistical manner typically seen for complex AI/ML medical devices. Therefore, much of the requested information regarding statistical studies, expert adjudication, and sample sizes for training/test sets is not available in this document.
However, I can extract the information that is present and highlight the type of testing performed.
Type of Device: Surgical Trocar (not an AI/ML device)
Given that this is a 510(k) submission for a surgical trocar, physical and chemical performance tests are presented, not diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device testing (e.g., MRMC studies, ground truth establishment for AI, training set size) are not applicable or detailed in this document.
1. Table of Acceptance Criteria and Reported Device Performance
For a surgical trocar, acceptance criteria are generally qualitative or based on passing specific physical, chemical, and biological tests. The document describes the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices," implying successful completion of these tests. Specific numerical acceptance criteria or performance values are not provided in this summary.
| Test Type | Test Method | Reported Performance / Conclusion |
|---|---|---|
| Sterilization Validation | ISO 11737-1 | Met standard, supports substantial equivalence. |
| Shelf Life Validation | Not specified (implied to meet requirements) | Met requirements, supports substantial equivalence. |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Met standard, supports substantial equivalence. |
| Biocompatibility: EO Sterilization Residuals | ISO 10993-7 | Met standard, supports substantial equivalence. |
| Biocompatibility: Skin Sensitization | ISO 10993-10 | Met standard, supports substantial equivalence. |
| Biocompatibility: Systemic Toxicity | ISO 10993-11 | Met standard, supports substantial equivalence. |
| Biocompatibility: Irritation | ISO 10993-10 | Met standard, supports substantial equivalence. |
| Performance: Appearance | Visual Inspection | Met visual requirements. |
| Performance: Measurement | Inspecting dimensions using vernier calipers | Met dimensional requirements. |
| Performance: Leakage | When the sample was put air in trocar sleeve with air pressure after close the valve, it should not be leaked. (Bubble test for Intraperitoneal Pressure Test) | No leakage detected. |
| Performance: Extraction Test | Appearance, pH, KMnO4, Evaporating residue, Heavy Metal, UV-vis Spectrum (This seems to describe tests on extractables, not mechanical extraction of the device.) | Met requirements. |
| Non-Clinical (Animal) Test: Trocar Insertion & Extraction | The operator (expert veterinarian) scored the experience when the trocar was inserted into the abdominal cavity of animals and extracted according to pre-set scoring index. Insertion, Fixation, and Extraction were evaluated. | Good performance, comparable to predicates. |
| Non-Clinical (Animal) Test: Intraperitoneal Pressure | The time for intraperitoneal pressure to reach a certain mmHg was recorded. And the bubble test was performed to check the leakage of gas. Time to insufflation was evaluated. The text states "bubble test was performed to check the leakage of gas," which relates to the previous leakage test of the device itself. The time to reach certain mmHg and insufflation time seem to relate to the system as a whole with the trocar. | Acceptable pressure maintenance and insufflation time. |
| Non-Clinical (Animal) Test: Convenience of performing laparoscope | The operator inserted the laparoscope through the trocar needle of optical test devices and scored the convenience of performing laparoscope according to the scoring index demonstrated below. Visualization was also evaluated. | Convenient, good visualization. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in the document for any of the performance tests. For animal testing, it mentions "micropigs" but not the number of animals used.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study is described as "Non-Clinical(Animal) test using micropigs," implying a prospective animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the non-clinical (animal) tests, it states "The operator (expert veterinarian) scored the experience." This indicates at least one expert, but the exact number and detailed qualifications (e.g., years of experience) are not provided beyond "expert veterinarian." This is not a "ground truth" establishment in the sense of clinical disease diagnosis, but rather an expert evaluation of device performance.
4. Adjudication method for the test set
- Not applicable/Not described. The expert veterinarian "scored the experience," suggesting a single evaluation per test, not a consensus or adjudication process involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
- No. This type of study is relevant for diagnostic devices (especially AI/ML image analysis) where human reader performance is being evaluated or compared. It is not applicable for a surgical trocar.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this device. For the performance tests, the "truth" is determined by meeting engineering specifications, ISO standards, and the assessment by an expert veterinarian for handling characteristics in an animal model.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Summary specific to the provided document:
The provided document describes a 510(k) submission for a surgical trocar (Laport®). The "acceptance criteria" discussed are primarily compliance with ISO standards for sterilization, biocompatibility, and various physical and mechanical performance tests (e.g., appearance, measurement, leakage, extraction). A non-clinical animal test was also conducted, where an "expert veterinarian" evaluated the device's insertion, fixation, extraction, intraperitoneal pressure management, and convenience for laparoscope use.
The document states that all tests demonstrated that the device is "substantially equivalent to the predicate devices." However, it does not provide quantitative performance metrics, specific numerical acceptance thresholds, or statistical analysis of the test results. The sample sizes for these tests are also not specified in this summary. This is typical for 510(k) summaries for such devices, where the focus is on demonstrating equivalence through a battery of standard tests rather than detailed statistical clinical trials, especially if it's not a novel technology or an AI/ML device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.